Heavy DrinkingNCT05398315

Interactive Alcohol Decision-Making Programs

A study testing Empathic Statements/Reflections, Narrator Backstory and Male Narrator in people with Heavy Drinking, run by Wayne State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Heavy Drinking
What is being tested?: Empathic Statements/Reflections, Narrator Backstory and Male Narrator
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 352 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2021to 1 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Over age 18
Access to the internet.
Males must consume at least 14 drinks per week or 4 drinks per day
Females must consume at least 7 drinks per week or 3 drinks per day

Who cannot join

Under age 18
No internet access
Males who consume less than 14 drinks per week or 4 drinks per day
Females who consume less than 7 drinks per week or 3 drinks per day

Trial locations and contacts

1 site in 1 country.

United States1 site

Wayne State University
Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: Testing the Efficacy of Interactive Alcohol Decision-Making Program

This project aims to develop a maximally effective, computer-delivered brief intervention (CDBI) for reducing heavy alcohol use. More specifically, the investigators will examine outcomes of different versions of a CDBI in which the presence/absence of empathic statements, the gender of the narrator, the presence/absence of a narrator backstory, and the use/non-use of motivational interviewing techniques are systematically manipulated using a factorial design. Participants (352 heavy drinkers) will be randomly assigned to 1 of 16 intervention conditions, representing all combinations of the 4 variables being manipulated. The investigators hypothesize that there will be significant main effects of all four factors being manipulated on (a) subjective reactions to the CDBI and (b) alcohol outcomes at 1-month follow-up

Read the detailed description

The National Survey on Drug Use and Health estimates that 19.3 million individuals ages 12 and over met criteria for an alcohol use disorder in the past year, fully 87.4% of whom neither received any treatment in the past 12 months, nor wanted it. Recognition of this tremendous gap has led to efforts, both nationally and internationally, to implement proactive screening and brief intervention. Brief interventions have proven efficacious in reducing unhealthy drinking with effect sizes in meta-analyses ranging from small to moderate. Brief interventions are also uniquely applicable to non-treatment-seeking populations, who may refuse extended treatment but accept a minimal, opportunistic intervention. However, the public health impact of brief interventions has been limited by substantial difficulty with implementation. Further, positive overall findings in meta-analyses obscure the results of multiple rigorous efficacy trials showing no brief intervention effect on alcohol use. Both of these issues-the implementation challenges and the inconsistency in outcomes-suggest that changes are needed before brief alcohol interventions can meet their full potential.

Technology offers exciting potential in both respects. First, computer-delivered brief interventions (CDBIs) can be presented inexpensively, with perfect fidelity, and without the need for training or provider time. Second, their replicability, flexibility, and modularity makes them the perfect platform for (a) isolating the active ingredients that are associated with positive outcomes; and thereby (b) continually optimizing CDBIs to achieve cumulative increases in efficacy.

The overall goal of this research is to develop a maximally effective and replicable CDBI for reducing heavy alcohol use. To accomplish this, the investigators will use the Multiphase Optimization Strategy (MOST), an efficient method for optimizing intervention content that uses factorial designs to evaluate main and interaction effects of specific intervention components. The selection of components will be guided by: (a) Common Factors Theory, which highlights the tremendous contribution of relational factors, such as empathy, alliance and positive regard to therapy outcomes, but which is of unknown relevance to CDBIs; and (b) the Media Equation Theory, which suggests that people automatically respond to computers in social ways, particularly when those computers replicate human characteristics. Guided by this literature, the investigators will examine outcomes of a CDBI in which empathic statements, the gender of the narrator, the presence/absence of a narrator backstory, and the use/non-use of motivational interviewing techniques are systematically manipulated using a factorial design.

Specific aims are as follows:

Develop 16 distinct, time-consistent, computer-delivered sessions representing all possible combinations of the following four factors (each of which will be binary; i.e. either present vs. absent or male vs. female): (1) narrator gender, (2) empathic statements and reflections, (3) narrator backstory, and (4) use of motivational techniques.
Evaluate main and interaction effects of the five factors by randomly assigning 352 heavy drinkers to the 16 sessions (each of the four factors being presented to half of the participants) and evaluating (1) subjective reactions to the CDBI at baseline and (2) alcohol use at 1-month follow-up.

Hypothesis 1. Subjective reactions to the CDBI, disclosure of alcohol use and consequences, and motivation to reduce alcohol use will be higher and alcohol use at follow-up will be lower in the presence of (1) empathic statements, (2) a narrator backstory and (3) motivational techniques. The effects of narrator gender will be examined in an exploratory way (i.e., no a priori hypotheses).

Hypothesis 2. Subjective reactions will be more positive, disclosure and motivation to reduce alcohol use will be higher, and alcohol use at follow-up will be lower when the two relational factors (empathy and narrator backstory) are combined with the presence of motivational content.

Conditions: Heavy Drinking
Being tested: Empathic Statements/Reflections, Narrator Backstory, Male Narrator, Female Narrator, MI Techniques
Keywords: Alcohol, Common Factors, Motivational Interviewing, Factorial Design

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Empathic Statements/ReflectionsBehavioural
Presence of Empathic Statements
Narrator BackstoryBehavioural
Presence of a narrator backstory
Male NarratorBehavioural
Presence of a male narrator
Female NarratorBehavioural
Presence of a female narrator
MI TechniquesBehavioural
Presence of MI techniques

Study groups in NCT05398315
Study group	Role	What they receive
Empathic Statements, MI, Male, No Backstory	Experimental	Presence of empathic statements and MI techniques. Male narrator. No narrator backstory. Receives: Behavioral: Empathic Statements/Reflections; Behavioral: Male Narrator; Behavioral: MI Techniques
No Empathic Statements, No MI, Female, No Backstory	Experimental	No empathic statements, MI techniques or narrator backstory. Female narrator Receives: Behavioral: Female Narrator
No Empathic Statements, No MI, Female, Backstory	Experimental	No empathic statements or MI techniques. Presence of narrator backstory. Female narrator Receives: Behavioral: Narrator Backstory; Behavioral: Female Narrator
Empathic Statements, MI, Female, Backstory	Experimental	Presence of empathic statements, MI techniques and narrator backstory. Female narrator Receives: Behavioral: Empathic Statements/Reflections; Behavioral: Narrator Backstory; Behavioral: Female Narrator; Behavioral: MI Techniques
No Empathic Statements, No MI, Male, No Backstory	Experimental	No empathic statements, MI techniques or narrator backstory. Male narrator Receives: Behavioral: Male Narrator
Empathic Statements, MI, Male, Backstory	Experimental	Presence of empathic statements, MI techniques and narrator backstory. Male narrator. Receives: Behavioral: Empathic Statements/Reflections; Behavioral: Narrator Backstory; Behavioral: Male Narrator; Behavioral: MI Techniques
No Empathic Statements, MI, Female, Backstory	Experimental	Presence of MI techniques and narrator backstory. No empathic statements. Female narrator. Receives: Behavioral: Narrator Backstory; Behavioral: Female Narrator; Behavioral: MI Techniques
Empathic Statements, No MI, Male, No Backstory	Experimental	Presence of empathic statements. No MI techniques or narrator backstory. Male narrator. Receives: Behavioral: Empathic Statements/Reflections; Behavioral: Male Narrator
No Empathic Statements, MI, Male, Backstory	Experimental	Presence of MI techniques and narrator backstory. No empathic statements. Male narrator. Receives: Behavioral: Narrator Backstory; Behavioral: Male Narrator; Behavioral: MI Techniques
Empathic Statements, No MI, Female, No Backstory	Experimental	Presence of empathic statements. No MI techniques or narrator backstory. Female narrator. Receives: Behavioral: Empathic Statements/Reflections; Behavioral: Female Narrator
Empathic Statements, MI, Female, No Backstory	Experimental	Presence of empathic statements and MI techniques. Female narrator. No narrator backstory. Receives: Behavioral: Empathic Statements/Reflections; Behavioral: Female Narrator; Behavioral: MI Techniques
No Empathic Statements, No MI, Male, Backstory	Experimental	Presence of narrator backstory. No empathic statements or MI techniques. Male narrator. Receives: Behavioral: Narrator Backstory; Behavioral: Male Narrator
Empathic Statements, No MI, Female, Backstory	Experimental	Presence of empathic statements and narrator backstory. No MI techniques. Female narrator. Receives: Behavioral: Empathic Statements/Reflections; Behavioral: Narrator Backstory; Behavioral: Female Narrator
Empathic Statements, No MI, Male, Backstory	Experimental	Presence of empathic statements and narrator backstory. No MI techniques. Male narrator. Receives: Behavioral: Empathic Statements/Reflections; Behavioral: Narrator Backstory; Behavioral: Male Narrator
No Empathic Statements, MI, Female, No Backstory	Experimental	Presence of MI techniques. No empathic statements or narrator backstory. Female narrator. Receives: Behavioral: Female Narrator; Behavioral: MI Techniques
No Empathic Statements, MI, Male, No Backstory	Experimental	Presence of MI techniques. No empathic statements or narrator backstory. Male narrator. Receives: Behavioral: Male Narrator; Behavioral: MI Techniques

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Quantity and Frequency of Alcohol Use
The Timeline Followback Questionnaire (TLFB) will be given to assess past month alcohol use.
Measured: Given pre-intervention and at 1-month follow-up
Change in Alcohol-Related Consequences
Assessed with the Brief Young Adult Alcohol Consequences Questionnaire which assess the occurrence/ non-occurrence of 24 alcohol consequences.
Measured: Given pre-intervention and at 1-month follow-up
Participant Satisfaction with the Intervention
Fifteen item measure assessing how much participants liked the intervention and felt respected by it.
Measured: Given immediately after completing the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20211 Apr 2023

First posted31 May 2022
Study start1 Jul 2021
Primary completion1 Apr 2023
Study completion1 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Heavy DrinkingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Model description: Four intervention components will be manipulated in a full factorial design, such that each participant either does or does not receive each intervention component.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 352 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05398315
Sponsor's protocol ID: 22-01-4352
Status last verified: Jun 2023
First submitted: 19 May 2022
Last updated: 6 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Grekin ER, Thomas HA, Ondersma SJ. Testing the efficacy of narrator empathy, self-disclosure, gender, and use of brief motivational interviewing techniques in a brief internet-based intervention for alcohol use. Psychol Addict Behav. 2024 May;38(3):231-242. doi: 10.1037/adb0001003. Epub 2024 Mar 14.
PubMed 38483522

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testing the Efficacy of Interactive Alcohol Decision-Making Program
ClinicalTrials.gov ID: NCT05398315
Acronym / sponsor ID: 22-01-4352
Conditions: Heavy Drinking
Keywords: Alcohol, Common Factors, Motivational Interviewing, Factorial Design
Study type: Interventional
Recruitment status: Completed
Enrolment: 352 participants (actual)
Lead sponsor: Wayne State UniversityUniversity, hospital or other
Study start: 1 Jul 2021 (actual)
Primary completion: 1 Apr 2023 (actual)
Study completion: 1 Apr 2023 (actual)
First posted: 31 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Specific aims are as follows:

Develop 16 distinct, time-consistent, computer-delivered sessions representing all possible combinations of the following four factors (each of which will be binary; i.e. either present vs. absent or male vs. female): (1) narrator gender, (2) empathic statements and reflections, (3) narrator backstory, and (4) use of motivational techniques.
Evaluate main and interaction effects of the five factors by randomly assigning 352 heavy drinkers to the 16 sessions (each of the four factors being presented to half of the participants) and evaluating (1) subjective reactions to the CDBI at baseline and (2) alcohol use at 1-month follow-up.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 16
Model description: Four intervention components will be manipulated in a full factorial design, such that each participant either does or does not receive each intervention component.

Arm	Type	Receives
Empathic Statements, MI, Male, No Backstory	Experimental	Behavioral: Empathic Statements/Reflections, Behavioral: Male Narrator, Behavioral: MI TechniquesPresence of empathic statements and MI techniques. Male narrator. No narrator backstory.
No Empathic Statements, No MI, Female, No Backstory	Experimental	Behavioral: Female NarratorNo empathic statements, MI techniques or narrator backstory. Female narrator
No Empathic Statements, No MI, Female, Backstory	Experimental	Behavioral: Narrator Backstory, Behavioral: Female NarratorNo empathic statements or MI techniques. Presence of narrator backstory. Female narrator
Empathic Statements, MI, Female, Backstory	Experimental	Behavioral: Empathic Statements/Reflections, Behavioral: Narrator Backstory, Behavioral: Female Narrator, Behavioral: MI TechniquesPresence of empathic statements, MI techniques and narrator backstory. Female narrator
No Empathic Statements, No MI, Male, No Backstory	Experimental	Behavioral: Male NarratorNo empathic statements, MI techniques or narrator backstory. Male narrator
Empathic Statements, MI, Male, Backstory	Experimental	Behavioral: Empathic Statements/Reflections, Behavioral: Narrator Backstory, Behavioral: Male Narrator, Behavioral: MI TechniquesPresence of empathic statements, MI techniques and narrator backstory. Male narrator.
No Empathic Statements, MI, Female, Backstory	Experimental	Behavioral: Narrator Backstory, Behavioral: Female Narrator, Behavioral: MI TechniquesPresence of MI techniques and narrator backstory. No empathic statements. Female narrator.
Empathic Statements, No MI, Male, No Backstory	Experimental	Behavioral: Empathic Statements/Reflections, Behavioral: Male NarratorPresence of empathic statements. No MI techniques or narrator backstory. Male narrator.
No Empathic Statements, MI, Male, Backstory	Experimental	Behavioral: Narrator Backstory, Behavioral: Male Narrator, Behavioral: MI TechniquesPresence of MI techniques and narrator backstory. No empathic statements. Male narrator.
Empathic Statements, No MI, Female, No Backstory	Experimental	Behavioral: Empathic Statements/Reflections, Behavioral: Female NarratorPresence of empathic statements. No MI techniques or narrator backstory. Female narrator.
Empathic Statements, MI, Female, No Backstory	Experimental	Behavioral: Empathic Statements/Reflections, Behavioral: Female Narrator, Behavioral: MI TechniquesPresence of empathic statements and MI techniques. Female narrator. No narrator backstory.
No Empathic Statements, No MI, Male, Backstory	Experimental	Behavioral: Narrator Backstory, Behavioral: Male NarratorPresence of narrator backstory. No empathic statements or MI techniques. Male narrator.
Empathic Statements, No MI, Female, Backstory	Experimental	Behavioral: Empathic Statements/Reflections, Behavioral: Narrator Backstory, Behavioral: Female NarratorPresence of empathic statements and narrator backstory. No MI techniques. Female narrator.
Empathic Statements, No MI, Male, Backstory	Experimental	Behavioral: Empathic Statements/Reflections, Behavioral: Narrator Backstory, Behavioral: Male NarratorPresence of empathic statements and narrator backstory. No MI techniques. Male narrator.
No Empathic Statements, MI, Female, No Backstory	Experimental	Behavioral: Female Narrator, Behavioral: MI TechniquesPresence of MI techniques. No empathic statements or narrator backstory. Female narrator.
No Empathic Statements, MI, Male, No Backstory	Experimental	Behavioral: Male Narrator, Behavioral: MI TechniquesPresence of MI techniques. No empathic statements or narrator backstory. Male narrator.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Over age 18
Access to the internet.
Males must consume at least 14 drinks per week or 4 drinks per day
Females must consume at least 7 drinks per week or 3 drinks per day

Key exclusion criteria (4 listed)

Under age 18
No internet access
Males who consume less than 14 drinks per week or 4 drinks per day
Females who consume less than 7 drinks per week or 3 drinks per day

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Empathic Statements/ReflectionsPresence of Empathic Statements	Behavioural	Empathic Statements, MI, Female, Backstory, Empathic Statements, MI, Female, No Backstory, Empathic Statements, MI, Male, Backstory, Empathic Statements, MI, Male, No Backstory, Empathic Statements, No MI, Female, Backstory, Empathic Statements, No MI, Female, No Backstory, Empathic Statements, No MI, Male, Backstory, Empathic Statements, No MI, Male, No Backstory
Narrator BackstoryPresence of a narrator backstory	Behavioural	Empathic Statements, MI, Female, Backstory, Empathic Statements, MI, Male, Backstory, Empathic Statements, No MI, Female, Backstory, Empathic Statements, No MI, Male, Backstory, No Empathic Statements, MI, Female, Backstory, No Empathic Statements, MI, Male, Backstory, No Empathic Statements, No MI, Female, Backstory, No Empathic Statements, No MI, Male, Backstory
Male NarratorPresence of a male narrator	Behavioural	Empathic Statements, MI, Male, Backstory, Empathic Statements, MI, Male, No Backstory, Empathic Statements, No MI, Male, Backstory, Empathic Statements, No MI, Male, No Backstory, No Empathic Statements, MI, Male, Backstory, No Empathic Statements, MI, Male, No Backstory, No Empathic Statements, No MI, Male, Backstory, No Empathic Statements, No MI, Male, No Backstory
Female NarratorPresence of a female narrator	Behavioural	Empathic Statements, MI, Female, Backstory, Empathic Statements, MI, Female, No Backstory, Empathic Statements, No MI, Female, Backstory, Empathic Statements, No MI, Female, No Backstory, No Empathic Statements, MI, Female, Backstory, No Empathic Statements, MI, Female, No Backstory, No Empathic Statements, No MI, Female, Backstory, No Empathic Statements, No MI, Female, No Backstory
MI TechniquesPresence of MI techniques	Behavioural	Empathic Statements, MI, Female, Backstory, Empathic Statements, MI, Female, No Backstory, Empathic Statements, MI, Male, Backstory, Empathic Statements, MI, Male, No Backstory, No Empathic Statements, MI, Female, Backstory, No Empathic Statements, MI, Female, No Backstory, No Empathic Statements, MI, Male, Backstory, No Empathic Statements, MI, Male, No Backstory

Primary outcome

Change in Quantity and Frequency of Alcohol Use
Time frame: Given pre-intervention and at 1-month follow-up
The Timeline Followback Questionnaire (TLFB) will be given to assess past month alcohol use.
Change in Alcohol-Related Consequences
Time frame: Given pre-intervention and at 1-month follow-up
Assessed with the Brief Young Adult Alcohol Consequences Questionnaire which assess the occurrence/ non-occurrence of 24 alcohol consequences.
Participant Satisfaction with the Intervention
Time frame: Given immediately after completing the intervention
Fifteen item measure assessing how much participants liked the intervention and felt respected by it.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
Derived from this study: PubMed 38483522Grekin ER, Thomas HA, Ondersma SJ. Testing the efficacy of narrator empathy, self-disclosure, gender, and use of brief motivational interviewing techniques in a brief internet-based intervention for alcohol use. Psychol Addict Behav. 2024 May;38(3):231-242. doi: 10.1037/adb0001003. Epub 2024 Mar 14.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emily Grekin, PhD principal investigator

Wayne State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Empathic Statements/Reflections, Narrator Backstory and Male Narrator in people with Heavy Drinking, run by Wayne State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Quantity and Frequency of Alcohol Use (time frame: Given pre-intervention and at 1-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05398315, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.